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    Summary
    EudraCT Number:2011-004910-41
    Sponsor's Protocol Code Number:WellmuneElderlyStudy1.1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-28
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-004910-41
    A.3Full title of the trial
    A Randomised Controlled Trial to assess a food supplement (baker’s yeast extract) to support immune function and prevent cold and flu symptoms in a 50 to 70 year old population
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomised Controlled Trial to assess a food supplement (baker’s yeast extract) to support immune function and prevent cold and flu symptoms in a 50 to 70 year old population
    A.3.2Name or abbreviated title of the trial where available
    Wellmune for the prevention of URTI in a 50 to 70 year old population
    A.4.1Sponsor's protocol code numberWellmuneElderlyStudy1.1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Southampton
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBiothera
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameWellmune WGP (1/3 1/6 glucopolysaccharide)
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN1,3/1,6 glucopolysaccharide
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4EV Substance CodeAS2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4EV Substance CodeAS3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeFood supplement
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    We aim to assess the number and severity of Upper Respiratory Tract Infection(URTI)Symptoms reported by participants over a 90 day period commencing in January 2012 in 100 healthy 50-70 year olds pre-screened to exclude symptomatic chronic respiratory or cardiac disease. We will also assess between group difference in immune function measuring LPS-stimulated cytokine and chemokine data and salivary immunoglobulins.
    E.1.1.1Medical condition in easily understood language
    We are aiming to assess the number and severity of cold and flu symptoms that people experience over 90 days e.g. runny nose, sore throat, cough.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal research objective is to assess the ability of a daily 1-3 1-6 glucopolysaccharide food supplement to prevent or reduce the number of cold and flu symptoms compared to a placebo capsule in a group of 50-70 year olds over a 90 day period. It also aims to assess the severity of any reported symptoms in those taking the supplement compared to placebo. We aim to measure this via daily completion by the participants of a brief health diary stating 1 (=no cold/flu symptoms), 2 (= cold symptoms - from a defined list) or 3 (=flu symptoms - from a defined list). If a participant reports two or more symptoms for two consecutive days then they contact the study team and start to complete a Wisconsin Score (WURSS-21) form which measures the total number and severity of all cold or flu symptoms and the impact this is having on ability to perform everyday tasks.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the effect of the supplement on immune function compared to the placebo treatment. It is proposed this is measured by comparing a blood and saliva sample at the start (Day 0), mid-point (Day 45) and end of the study period (Day 90). This will measure blood markers of immune function (cytokines and chemokines) at resting baseline and again after the blood sample has been tested with a substance mimicking an immune challenge (called LPS). This objective therefore aims to provide information to better understand the supplement's potential for improving immune function and increasing resistance to infection. A further secondary objective is to assess for any difference in the perception of general health and quality of life between those taking the active supplement and placebo treatment. This will be measured using a validated questionnaire called SF-8.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age 50-70 years •general good health •BMI 18-40 •consent to all study visits and procedures •community-dwelling •at least 1 self-reported cold in the last 12 months
    E.4Principal exclusion criteria
    • current symptomatic respiratory illness • current oral steroids use • current antibiotic or immunosuppressant medication • known immune or auto-immune disorders (including HIV, ankylosing spondylitis, Crohn’s Disease, Ulcerative Colitis) • low BMI/ eating disorders • severe renal or liver disease • symptomatic heart failure
    E.5 End points
    E.5.1Primary end point(s)
    The total number of days with URTI symptoms measured using a daily health log. A co-primary outcome is the severity of URTI symptoms as measured by daily WURSS-21 validated questionnaire measured daily during symptomatic URTI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of cold and flu symptoms will be performed on a daily basis by participants over the 90 day trial using a daily health log. This will record 1=no cold or flu symptoms, 2=cold symptoms(including a defined list of tyipcal symptoms to be reported), 3= flu symptoms (again from a list of typically defined flu-like symptoms). An extra questionnaire will be given to participants who experience an episode of cold or flu which involves at least 2 defined typical symptoms for 2 consecutive days. These individuals will complete a symptom assessment for severity of symptoms (WURSS-21) on each symptomatic day. This classifies a wide variety of symptom categories such as sore throat, blocked nose, cough on a likert scale 0-7 (not present to severe) during any periods of confirmed URTI.
    E.5.2Secondary end point(s)
    Analysis of bio-markers of immune function. Blood samples - will be analysed by Professor Calder's team for a range of plasma cytokines and chemokines (measured by flow cytometry based upon eBiosciences kits) and culture supernatant chemokines and cytokines (flow cytometry based upon eBiosciences kits), measured pre and post addition of LPS. Chemokines to be measured will be IL-8, MIP-1a, MIP-1b, MCP-1, MIG, G-CSF. Cytokines to be measured will be IL-1b, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12, IL-13, IL-17A, IL-22, TNF-a, IFN-g. Saliva samples - will be analysed for immunoglobulins using immunoassay. It is intended that these tests will provide information on the baseline effects of the supplement on immuen function - both at rest, and after potential immune challenge as stimulated by LPS. This therefore provides new data on the mechanism of the supplement in the study population of 50-70 year olds. this will help to prpovide information on whether immune function may be modified in its resting state using the supplement or only when the body's immune system faces an infectious challenge as modelled by adding LPS to the samples. This could allow a much broader understanding of the potential role of the supplement in infection control. Comparison of response to placebo would also highlight if there is potential to improve the usual pattern of immunosenescence (age-related immune decline) which occurs over the age of 50 years approximately. It is not felt that this data risks causing any harm to the participant. On an individual level these biomarkers are not predictive of specific disease risks and would not affect insurance or medical status. A further secondary outcome relates to genberal health perception as measured by a validated questionnaire - SF-8.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A blood and saliva test will be taken to monitor immune function at the start of the study (pre-treatment), again at Day 45 (mid-point) and finally at Day 90 (last day of treatment). SF-8 questionnaires will be given at these same time points. There will be no further trial assessments after Day 90.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Pilot trial(n=100)
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    Pilot study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If a participant wishes to know if they were taking the placebo or supplement then this information will be provided to them after the unblinding process is complete at the end of the study period. At that time, should those participating wish to continue with the food supplement then they would be able to purchase this over the counter.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-30
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